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Tart Cherry Juice and Chronic Disease Risk

Primary Purpose

CVD, Diabetes, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Tart cherry juice
Sponsored by
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CVD focused on measuring obese, overweight, tart cherry juice

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • This study was a 12-week 2 x 2 crossover, randomized, placebo-controlled dietary intervention in overweight and obese participants (BMI>25.0 kg/m2) who are more likely to exhibit >1 of the 5 risk conditions associated with metabolic syndrome (MetS). BMI was the minimal criterion for recruitment.

Exclusion Criteria:

  • Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Tart cherry juice (TCJ)

    Arm Description

    Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half of participants began study consuming placebo beverage and the other half TCJ.

    Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half pf participants began study consuming placebo beverage and the other half TCJ.

    Outcomes

    Primary Outcome Measures

    TCJ and hsCRP
    high-sensitivity C-reactive protein (hsCRP), a marker of inflammation

    Secondary Outcome Measures

    fasting triglycerides
    Blood lipid and risk factor for CVD

    Full Information

    First Posted
    August 16, 2018
    Last Updated
    August 16, 2018
    Sponsor
    University of Memphis
    Collaborators
    Arizona State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03638362
    Brief Title
    Tart Cherry Juice and Chronic Disease Risk
    Official Title
    Effect of Tart Cherry Juice on Inflammation and Dyslipidemia in Overweight and Obese Humans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 21, 2009 (Actual)
    Primary Completion Date
    September 30, 2011 (Actual)
    Study Completion Date
    September 30, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Memphis
    Collaborators
    Arizona State University

    4. Oversight

    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this study, the investigators recruited at-risk individuals (n=10) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with Metabolic Syndrome (MetS). In this 10-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants (n=10) to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or authentic TCJ for 4 weeks, followed by a 2-week washout period, then consumption of the alternate beverage for 4 weeks. In this study, the investigators determined the effect of TCJ in at-risk participants on markers of inflammation, glycemia, and lipidemia.
    Detailed Description
    In this study, the investigators recruited at-risk individuals (n=10) who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded. After enrollment, subjects were randomly assigned to consume daily either 240 mL (8 ounces) of authentic TCJ (R.W. Knudsen, Chico, CA) or a placebo beverage (commercial fruit punch; Great Value, Bentonville, AR) for 4 weeks. After a 2-week washout period, participants consumed the alternate beverage for 4 weeks in this 10-week 2x2 crossover, placebo-controlled dietary intervention. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of lipidemia (HDL, LDL, triglycerides, VLDL, total cholesterol), glycemia (fasting insulin and glucose, HOMA, QUICKI, McAuley indirect indices), and inflammation (hsCRP, TNF-alpha, and ESR).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CVD, Diabetes, Inflammation
    Keywords
    obese, overweight, tart cherry juice

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Crossover Assignment In this study, the investigators recruited at-risk individuals who were overweight (25.0-29.9 kg/m2) and obese (> 30.0 kg/m2) and likely to exhibit one or more conditions associated with MetS. In this 10-week placebo-controlled 2 x 2 crossover dietary intervention, the investigators randomized participants to consume 240 mL (8 ounces) daily of either placebo (artificial cherry-flavored, anthocyanin-free beverage) or authentic TCJ for 4 weeks, followed by a 2-week washout period, then consumption of the alternate beverage for 4 weeks. Subsequently, the investigators determined the effect of TCJ in at-risk participants on markers of inflammation, glycemia, and lipidemia.
    Masking
    Participant
    Masking Description
    Placebo beverage was selected from commercially available, artificially flavored and colored fruit punches (Great Value fruit punch, Bentonville, AR) to match a closely as possible the color (red) of the TCJ.
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half of participants began study consuming placebo beverage and the other half TCJ.
    Arm Title
    Tart cherry juice (TCJ)
    Arm Type
    Experimental
    Arm Description
    Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 2 week washout then switch over to the alternate beverage. Approximately half pf participants began study consuming placebo beverage and the other half TCJ.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants consumed placebo beverage for 4 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Tart cherry juice
    Intervention Description
    Participants consumed tart cherry juice (8 ounces; 240 mL) per day for four weeks.
    Primary Outcome Measure Information:
    Title
    TCJ and hsCRP
    Description
    high-sensitivity C-reactive protein (hsCRP), a marker of inflammation
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    fasting triglycerides
    Description
    Blood lipid and risk factor for CVD
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: This study was a 12-week 2 x 2 crossover, randomized, placebo-controlled dietary intervention in overweight and obese participants (BMI>25.0 kg/m2) who are more likely to exhibit >1 of the 5 risk conditions associated with metabolic syndrome (MetS). BMI was the minimal criterion for recruitment. Exclusion Criteria: Participants were >18 years of age, not pregnant, not diabetic, with no unresolved infections or diseases (diabetes, CVD, IBD, cancer and liver disease), and nonsmokers. Histories of medication and dietary supplement use were collected and those taking anti-inflammatory or lipid-lowering medications were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keith R Martin, PhD, MTox
    Organizational Affiliation
    Principal Investigator, School of Health Studies
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Coded data will be available to relevant parties, e.g., investigators, recognized scientific bodies, etc. upon reasonable request within an adequate time frame. Emails may be directed to the Principal Investigator.

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    Tart Cherry Juice and Chronic Disease Risk

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